Effects of Moderate Carbohydrate Consumption on Metabolic and Obstetric Outcomes in Pregnant Women With Insulin-treated Diabetes- A Randomized Controlled Trial

Recruiting now · Not applicable

Conditions studied: Diabetes in Pregnancy

In brief

Diabetes during pregnancy increases maternal and fetal complications, necessitating optimal glycemic control. The standard care diet (SCD, ≥175g/day carbohydrate) lacks robust evidence, particularly for pregnancies requiring intensive insulin treatment (IIT). This RCT investigates whether a moderate carbohydrate diet (MCD, ≤120g/day) versus SCD improves glycemic control and alters metabolomic profiles in pregnant individuals on IIT. Aims: To compare the efficacy and safety of a SCD versus MCD on glycemic control, metabolomic signatures, and pregnancy outcomes in pregnant individuals on IIT.

Key facts

Study ID

NCT06355154

Run by

Hadassah Medical Organization

People needed

120

Starts

2024-05-28

Expected to finish

2028-02-01

Last updated by the study team

2025-10-02

Who can join

Age: 18 and older, up to 45. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• • Pregnant women with singleton pregnancies.
• Over 18 years old.
• Diagnosis of GDM- 3-h 100-g OGTT according to the American College of Obstetricians and Gynecologists supported by the American Diabetes Association, Or Diagnosis of type 1 or 2 diabetes before pregnancy, Or Diagnosis of early GDM by either OGTT in the first trimester or elevated blood glucose measurements in the fasting (above 95mg/dl) or the postprandial (above 140 mg/dl) state.
• Are already on or intended to start intensive insulin treatment (at leased 2 injections of insulin per day) or wear an insulin pump.
• Are willing to wear a continuous glucose monitoring system.
• BMI of 18.5-42 kg/m2 at the time of diagnosis.

You may not qualify if…

• Individual with risk factors for:
• Placental insufficiency.
• Hypertension.
• Renal disease.
• Thrombophilia
• Rheumatologic disease.
• A history of preeclampsia, or fetal growth restriction (IUGR).
• Individuals with a history of preterm labor, or concomitant therapy with β-blockers or glucocorticoids.
• Individuals who smoke and/or consume any amount of alcohol during pregnancy.

Where it is running

• Hadassah Hospital — Jerusalem, Israel (enrolling)

Full record on ClinicalTrials.gov

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